Actively Recruiting
The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.
Led by Johnson & Johnson Medical (Shanghai) Ltd. · Updated on 2026-04-13
5000
Participants Needed
3
Research Sites
546 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll a minimum of 300 subjects per license, with participation from three or more medical institutions.
CONDITIONS
Official Title
The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women who have received Mentor breast implants per product instructions
- Ability to understand study procedures and consent to use of preoperative and surgical data
- Willingness to participate in postoperative follow-up assessments
- Capability to read, write, and provide informed consent by signing the consent form
- At least 22 years old at the time of implantation surgery
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Sichuan Huamei Zixin Medical Aesthetic Hospital
Chengdu, China, 610000
Actively Recruiting
2
Shenzhen Yixing Medical Cosmetology Hospital
Shenzhen, China, 518000
Actively Recruiting
3
Shenzhen Junke Medical Cosmetology Clinic
Shenzhen, China, 519000
Actively Recruiting
Research Team
S
Study Contact
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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